Bone graft shaper &amp; patient specific bone graft

ABSTRACT

Joint prosthesis methods and apparatuses are provided. A bone graft blank is placed in the chamber of the bone press facing a contoured surface. The contoured surface can be part of the bone press or can comprise a surface of a patient specific negative that can be inserted into the bone press. A bone contact surface of the bone graft blank is disposed in the chamber to face the contoured surface of the patient specific insert negative. The bone contact surface of the bone graft blank is compressed against the contoured surface. The bone contact surface can be reshaped to form a patient specific bone graft.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

Any and all applications for which a foreign or domestic priority claimis identified in the Application Data Sheet as filed with the presentapplication are hereby incorporated by reference under 37 C.F.R. §1.57.

BACKGROUND OF THE INVENTION Field of the Invention

This application is directed to patient specific methods and devicesuseful in shoulder arthroplasty and other joint and orthopedic surgery.

Description of the Related Art

Arthroplasty is the standard of care for the treatment of advancedshoulder joint problems, such as severe arthritis. Shoulder arthroplastycan replicate the anatomical form of a joint, with a spherical componentmounted on the proximal humerus and a concave surface mounted on theglenoid region of the scapula. Certain patients benefit from a reverseshoulder reconstruction in which a spherical component is mounted to thescapula and a concave surface is positioned on the proximal humerus.Articulation of the spherical component on the concave surface providesthe patient with improved arm motion.

One leading reverse shoulder technique, known as bony increased offsetreverse shoulder arthroplasty or BIO-RSA provides improved outcomes forpatients. BIO-RSA involves placing a spacer between the glenoid regionof the scapula and a spherical joint component that is coupled with theglenoid. Among other benefits, BIO-RSA can improve range of motion,limit notching of the scapula, and correct bone deficiency.

Surgeons currently use standard spacers in BIO-RSA, for example withmedial and lateral surfaces parallel to each other, disposed at a 12.5degree angle relative to each other, and with limited options forthickness, such as 7 mm or 10 mm. In cases where the glenoid regionsurface is worn and may have missing bone portions a spacer with a flatsurface will not seat properly against the glenoid and early looseningof the implant can result from improper seating. Further, in cases wherethe glenoid region surface is worn and may have missing bone portionsexcessive reaming of the bone may be needed to establish a flat surfaceon which a spacer can be seated. However excessive reaming of theglenoid surface can remove the dense subchondral bone and expose thesoft and porous cancellous bone which is a poor seating surface for thespacer. Early loosening of the implant can be a consequence of excessivereaming. What is needed is a spacer than can conform to the worn glenoidsurface without excessive reaming of the scapula.

SUMMARY OF THE INVENTION

A great improvement in BIO-RSA and other procedures that would benefitfrom adjusting lateral position of a component on a scapula would resultif methods and systems could form and employ patient specific spacers.Patient specific spacers would better adapt to patient joint surfaceshape, for example at or around the glenoid surface of the scapula.Patient specific spacers can be formed anticipating that some reamingmay occur, but that the glenoid will not be altered as extensively as ina conventional procedure. Patient specific spacers can be formed basedon information about the condition and/or the shape of the joint surfaceof the patient to be augmented by a spacer. The patient information canbe collected by a CT scan or by any other surface characterizationtechnology. Thereafter, the patient information can be used as an inputto shape a spacer from a bone graft material. The system and method canbe used to shape any one or more of a section of bone from a proximalportion of the humerus, an allograft, a synthetic bone, or anotherstructure. In a preferred embodiment the spacer is formed from a unitarypiece of bone. The system and method can be used to form a plurality ofpieces of bone or synthetic bone stock into a solid, unitary patientspecific spacer.

In one embodiment a joint prosthesis method is provided. A firstprosthesis component is placed in a chamber of a bone press. The firstprosthesis component has a first side, e.g., a medial side, and a secondside, e.g., a lateral side, oriented away from the first side, e.g., themedial side. A bone graft blank is placed in the chamber of the bonepress between a contoured surface of a patient specific insert negativeand the first prosthesis component. A bone contact surface of the bonegraft blank faces, e.g., is in contact with, the contoured surface ofthe patient specific insert negative when so placed. The bone contactsurface of the bone graft blank is compressed against the contouredsurface of the patient specific insert negative. The bone contactsurface is reshaped to form a patient specific bone graft.

In a variation of the foregoing method, three dimensional spatiallocation information of a lateral portion of a bone is obtained. Thecontoured surface of the patient specific insert negative is formedbased on the three dimensional spatial location information. The threedimensional spatial location information can be information of or from ascapula, e.g., including information of or from at least a portion of aglenoid surface.

In a variation of the foregoing methods, the first (e.g., medial) sideof the first prosthesis component can be a side oriented toward aglenoid of a shoulder joint when applied and the second (e.g., lateral)side can be oriented toward a second prosthesis component coupled withthe humerus. In an elbow method, the first prosthesis component cancomprise a portion of a distal humeral component of a prosthetic elbowjoint and the second side can face a bone such as a resected humerusLikewise, if the second side faces a second joint component, the firstside could face a bone such as resected, reamed or otherwise preparedradius and/or unla of the patient.

In another embodiment, a joint prosthesis method is provided. Aprosthesis component is placed in a chamber of a bone press. Theprosthesis component has a first side, e.g., a medial side, and a secondside, e.g., a lateral side. The first side is configured to beorientated toward the patient, e.g., toward a glenoid. The second sideconfigured to articulate with another prosthesis component whenimplanted, e.g., with a humeral component. A bone graft blank is placedin the chamber of the bone press between a contoured surface and theprosthesis component. The contoured surface can be part of the bonepress or can comprise a surface of a patient specific negative that canbe inserted into the bone press. A bone contact surface of the bonegraft blank is disposed in the chamber to face, e.g., to be in contactwith, the contoured surface of the patient specific insert negative. Thebone contact surface of the bone graft blank is compressed against asurface in the bone press, e.g., against the contoured surface of theinsert negative. The bone contact surface is reshaped to form a patientspecific bone graft.

In another embodiment a method of forming a bone press component isprovided. Three dimensional spatial location information of a boneportion of a joint is obtained. A patient specific insert negative isformed. The patient specific insert negative has a contoured surfacethat is based on the three dimensional spatial location information. Thepatient specific insert negative is configured to be mounted on a bonepress and to shape a bone graft blank upon application of pressure inthe bone press.

In the method described in the preceding paragraph, the joint can be ashoulder joint and the contoured surface can match, replicate orotherwise correspond to a surface of the glenoid. The surface to whichthe contoured surface is matched, replicates or to which the surfaceotherwise corresponds can be that of the glenoid before or after a bonepreparation process such as reaming, drilling or cutting. In othervariations, the joint can be an elbow joint and the contoured surfacecan match, replicate or otherwise correspond to a surface of thehumerus. The surface to which the contoured surface is matched,replicates or to which the surface otherwise corresponds can be that ofthe humerus before or after a bone preparation process such as reaming,drilling or cutting.

In another embodiment a method of forming a patient specific bone graftis provided. A bone press is provided that has a patient specific insertnegative disposed in a pressing zone thereof. The patient specificinsert negative has a contoured surface that is based on threedimensional spatial location information of a bone portion to which thepatient specific bone graft is to be coupled. A bone graft blank isplaced into the pressing zone. The bone graft blank is compressedagainst the contoured surface of the patient specific insert negative.The compression causes a bone contacting surface of the bone graft blankto conform to the contoured surface of the patent specific insertnegative. A patient specific bone graft is thereby formed.

In another embodiment, a bone press is provided. The bone press includesa base, a compression plate, and a housing. The compression plate isdisposed opposite of the base. The housing is configured to extendbetween the base and the compression plate. The housing extends along alongitudinal axis of the bone press when so placed. A pressing zone isdisposed within the housing and between the base and the compressionplate along the longitudinal axis of the bone press. An actuatorprovides relative movement between the compression plate and the base tocreate compression in the pressing zone.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments are depicted in the accompanying drawings forillustrative purposes, and should in no way be interpreted as limitingthe scope of the embodiments. Furthermore, various features of differentdisclosed embodiments can be combined to form additional embodiments,which are part of this disclosure.

FIG. 1 is a partial cross-section of a shoulder joint, includingportions of a scapula and a humerus as well as a reverse shoulder jointprosthesis components coupled therewith;

FIG. 1A is a partial cross-section of a scapula having a glenoidcomponent of an anatomical shoulder joint prosthesis coupled therewith;

FIG. 2 illustrates a method of forming a patient specific insertnegative, which can be used in a bone press, based on spatial locationinformation;

FIG. 3 illustrates a method of forming a patient specific bone graft,the graft being adapted for use in a joint replacement or repairprocedure;

FIG. 4 illustrates another method of forming a patient specific bonegraft, the graft being adapted for use in a joint replacement or repairprocedure;

FIG. 5 is a perspective view of one embodiment of a bone press;

FIGS. 6 and 6A are cross-sectional view of two embodiments of the bonepress of FIG. 5 taken at section plane 6-6;

FIG. 7(A) is a partial exploded view of the bone press of FIG. 5, with abone graft blank, and a glenoid baseplate removed from the bone press;

FIG. 7(B) is a partial exploded view of the bone press of FIG. 5, withthe glenoid baseplate and the bone graft blank disposed on a base of thebone press;

FIG. 7(C) is a partial exploded view of the bone press of FIG. 5, with ahousing of the bone press disposed over and around the glenoid baseplateand the bone graft blank;

FIG. 7(D) is an assembled view of the bone press of FIG. 5, with apatient specific insert negative disposed on the bone graft blank and atleast partially within a pressing zone of the bone press;

FIG. 7(E) is an assembled view of the bone press of FIG. 5 , with anactuator engaged with the patient specific insert negative prior tocompressing the bone graft blank in the pressing zone;

FIG. 7(F) shows a patient specific bone graft that can be formed in thebone press of FIG. 5;

FIG. 8(A) shows a perspective view of a first embodiment of a patientspecific insert negative;

FIG. 8(A)-1 is a bottom view of the patient specific insert negativeshown in FIG. 8(A);

FIG. 8(B) shows a perspective view of a second embodiment of a patientspecific insert negative;

FIG. 9 is a perspective view of a second embodiment of a bone press inwhich an end of a baseplate impactor is disposed in a pressing zone ofthe bone press during the formation of the patient specific bone graftand in which compression being applied in the pressing zone by actuatinga threaded coupling;

FIG. 10 is a cross-section of the bone press of FIG. 9 taken along theplane 10-10;

FIG. 11(A) is a partial exploded view of an impactor, a joint prosthesiscomponent, and a bone graft blank that can be placed in a bone press toform a patient specific bone graft on the impactor;

FIG. 11(B) is a partial exploded view similar to that of FIG. 11(A)showing the joint prosthesis component mounted on the impactor;

FIG. 11(C) is a partial exploded view of the bone press of FIG. 10showing an end of an impactor, a joint prosthesis component, and a bonegraft blank disposed on a surface of a structure partially forming apressing zone;

FIG. 11(D) is a partial exploded view similar to that of FIG. 11(C)showing a compression member placed on a lower shell of a base of thebone press, the lower shell partially forming a housing disposed aroundthe pressing zone;

FIG. 11(E) is a partial exploded view similar to FIG. 11(C) showing anupper shell placed over the lower shell to form a housing disposedaround the pressing zone;

FIG. 12 is a perspective view of a third embodiment of a bone press inwhich a non-threaded actuator, e.g., a lever, applies compression in apressing zone during the formation of a patient specific bone graft;

FIG. 13 is partial cross-sectional view of the bone press of FIG. 12taken along section plane 13-13;

FIG. 14(A) is a partial exploded view of the bone press of FIG. 12 withan impactor, a joint prosthesis component, and a bone graft blankreceived in and on a base thereof; and

FIG. 14(B) is an assembled view prior to actuation of a lever to applycompression in the pressing zone, with a housing disposed around thebone graft blank and the patient specific insert negative coupled with acompression plate.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

While the present description sets forth specific details of variousembodiments, it will be appreciated that the description is illustrativeonly and should not be construed in any way as limiting. Furthermore,various applications of such embodiments and modifications thereto,which may occur to those who are skilled in the art, are alsoencompassed by the general concepts described herein. Each and everyfeature described herein, and each and every combination of two or moreof such features, is included within the scope of the present inventionprovided that the features included in such a combination are notmutually inconsistent.

This application is directed to patient specific bone grafts, methodsfor forming and using, as well as apparatuses for forming, such grafts.As discussed above, patient specific grafts can be clinically useful insupplementing eroded, thin or weak bone to which a prosthesis component,such as a glenoid baseplate, is to be coupled. BIO-RSA is one procedurewhere such grafts can be used. The apparatuses and methods disclosedherein enable novel and less traumatic bone preserving joint replacementtechniques. The apparatuses and methods disclosed herein can extendorthopedic treatments to patients who would otherwise not be treatableand can help preserve the possibility of future revisions if needed.

FIG. 1 shows a shoulder prosthesis 1 comprising a glenoid component 10implanted in the scapula S and a humeral component 20 implanted in thehumerus H of a patient's shoulder. The glenoid component 10 has a head11 which has, on a lateral side, a convex articular surface 11A ofgenerally hemispherical shape. The lateral side is a side facing awayfrom the glenoid surface G of the scapula S. The head 11 has an opposingface 11B disposed on a medial side. The medial side is a side facingtoward the glenoid surface. In FIG. 1, the face 11B is generally planarbut the face 11B can have other shapes. FIG. 1 illustrates what issometimes referred to as a reverse should prosthesis because theposition of the convex portion of the shoulder joint is the opposite ofthat of normal anatomy.

FIG. 1A shows another approach to shoulder replacement where a component10′ having a concave surface 32 is mounted to the glenoid G. Thecomponent 10′ is sometimes referred to herein as a baseplate, though abaseplate can include any structure of a prosthesis that directlycontacts a side of a bone graft. The concave surface 32 is configured toreceive a spherical member of a humeral component. An opposing face 34of the component 10′ is oriented toward the glenoid G. The surface 32 ison a lateral side of and the face 34 is on the medial side of thecomponents 10′.

The glenoid components 10, 10′ can also comprise an anchor member 12that extends from the face 11B (or the face 34) in the direction awayfrom the face 11A (or the surface 32). The free end of the anchor member12 is securely anchored in the scapula S through the glenoid surface Gwhen these components 10, 10′ are implanted to join the components tothe scapula S. By way of non-illustrated variation, the anchor member 12can be externally threaded or, generally, have a surface state promotingbony ingrowth or other mode of anchoring. The anchor member 12 can beseparable from or a unitary construction with other the component 10,10′.

A bone graft 2 is positioned between the glenoid surface G and the face11B, 34 of the respective glenoid components 10, 10′. The bone graft 2has a periphery 2A and a lateral surface 2B. The lateral surface 2B islocated on the side of the bone graft 2 disposed away from the glenoidsurface G. The lateral surface 2B is covered by the face 11B of the head11 or by the face 34 of the baseplate 10′. A medial surface 2C of thebone graft 2 faces and usually is in direct contact with the glenoidsurface G. Once the bone graft 2 fuses with the glenoid surface G, theeffective glenoid surface is displaced laterally outward to the distalsurface 2B of the bone graft 2.

FIG. 1 shows that the bone graft 2 can have a non-constant thickness.For example, a dimension L₁ at the inferior portion of the glenoid canbe smaller than a dimension L₂ at a superior portion. Providing greatermedial-lateral thickness at the superior portion can compensate forwear. Because the bone degradation or wear of every patient isdifferent, the best thickness of the bone graft 2 for superior andinferior portions can be different for each given patient. Specificmethods and apparatuses to discern the best thickness profile or otherconfiguration of the bone graft 2 and to form the bone graft accordinglyare discussed hereinbelow. More particularly, the medial face 2Cpreferably has a three-dimensional morphology that matches thethree-dimensional morphology of, e.g., is a negative of, the glenoid orof the glenoid as the clinician intends to modify it prior to mountingthe glenoid component 10, 10′ to the scapula.

Methods Related To Making Patient Specific Bone Grafts

A number of methods can be employed to make bone grafts for a jointprocedure that are specific to a particular patient. These methods canbe performed by a manufacturer of prostheses, by an imaging serviceprovider, by a surgeon, or by a combination of an imaging serviceprovider, a manufacturer, and a surgeon at the direction and under thecontrol of the surgeon or other participants in these processes.

FIG. 2 shows an embodiment of a method 100 for making a patient specificinsert negative 800. FIG. 8(A) shows an example of the patient specificinsert negative 800. The patient specific insert negative 800 isreferred to as a negative because, as discussed further below, acontoured surface 808 thereof has a shape that matches but is theopposite or is the negative of a shape to be formed on a bone graftblank B. The bone graft blank B is in turn a negative of a correspondingsurface of the glenoid. The negative 800 is sometimes referred to as an“insert” herein because in certain approaches, the negative 800 is aseparate component of a bone press and is inserted into the bone pressprior to making the patient specific bone graft. This approach allows abone press to be reusable while the negative 800 can be used for onespecific procedure, then discarded as discussed below. However, asdiscussed further below, a patient specific bone press could be used, inwhich the contoured surface 808 of the negative 800 is integrated intoand may not be inserted into nor removed from a bone press.

FIG. 2 shows a method that can be performed by or at the direction of amanufacturer of prosthetic joint components. In a step 104 threedimensional spatial location information of a bone portion of a joint isobtained. Any suitable technology can be used to obtain the spatiallocation information. For example, one or more imaging technologies suchas CT scanning, X-rays imaging or the like can be used to generatespatial location information. A mechanical device, such as aprofilometer could be used to generate spatial location informationwithout imaging. Three dimensional spatial location information can beobtained as one part of a broader process for characterizing the boneportion to determine how to treat the patient. For example, in the caseof performing a shoulder replacement, a degree of retroversion may bedetermined to assess whether to perform an anatomical shoulderreplacement (FIG. 1A) or a reverse shoulder replacement (FIG. 1).

In a step 108, the patient specific insert negative 800 is formed. Asdiscussed above, the negative 800 is configured with a contoured surface808 to be an opposite of the bone graft to be formed in a bone press.The shape of the contoured surface 808 can be derived from theinformation concerning a bone portion that was characterized in the step104. Therefore the step 108 can include shaping a first side 804 of thenegative 800 based upon the three dimensional information. The patientspecific insert negative 800 is configured to be advanced intoengagement with a side of a bone graft blank B as shown in FIGS. 6 and7(A). As discussed in more detail below, the bone graft blank B includesa volume, e.g., a cylinder or a plurality of pieces, of bone matter thatdoes not necessarily match the shape of the glenoid surface or otherbone portion analyzed in connection with step 104. In certain methods,the shape of the bone graft blank B is altered by being compressedagainst the negative 800 in a bone press. The negative 800 thus must besufficiently stiff to retain the shape that is based upon the threedimensional information obtained in the step 104.

FIGS. 8(A) and 8(B) show embodiments of patient specific insertnegatives 800, 800′. The insert negatives 800, 800′ includes the firstside 804 configured to change a generic shape of a surface of the bonegraft blank B or other bone material into a patient specific shape asdiscussed further below. The insert negatives 800, 800′ also include asecond side 806, 806′ opposite the first side 804. The insert negative800, 800′ also includes a peripheral surface 807 that extends betweenthe first side 804 and the second side 806, 806′. The first side 804 canincludes a contoured surface 808. The contoured surface 808 can have afirst portion 812 that corresponds to a portion of bone to be augmentedand a second portion 816 (best seen in FIG. 8(B), but correspondingsurfaces could be provided in the embodiment of FIG. 8(A)). The secondportion 816 can be configured to be mated with a portion of a bone thatis to be augmented differently. The second portion 816 can be configuredto be mated with a portion of a bone that is to be augmented by a lesseramount than the portion to which the first portion 812 of the contouredsurface 808 is to be mated to.

As discussed above, the surface 804 is an opposite of or a negative ofthe surface to be created on the bone graft blank B. Accordingly, thesecond portion 816 which is configured to form the zone to providelesser augmentation on the bone graft blank B extends away from thesecond side 806, 806′ by a first amount. The first portion 812 which isconfigured to form a zone of greater augmentation on the bone graftblank B extends away from the second side 806, 806′ by a second amountless than the first amount which is provided in the second portion 816.In one embodiment, the second portion 816 comprises a planar surfacedisposed in a plane that is perpendicular to a direction of compressionC in a bone press. The direction of compression C can be generally alongan axis extending through a central aperture 828 of the patient specificinsert negative 800, 800′. The first portion 812 can be a planar portionthat is disposed along a plane that is oriented at an acute angle to theaxis C. The second portion 816 can be inclined toward the second side806. The first portion 812 can have a boundary contiguous with thesecond portion 816 and can be spaced away from the plane of the secondportion at locations away from the contiguous boundary. An advantage ofproviding two planar portions is that it enables the surgeon to performtwo reaming steps to create two planar bone surfaces to which planarsurfaces of a patient specific bone graft formed by the negative 800 canbe mated.

One skilled in the art will recognize that more complex shapes can beformed by forming the first and second portion 812, 816 with complexgeometries or by providing more portions on the first side 804 resultingin a more complex contoured surface 808. The advantages of more complexcontoured surfaces include allowing the patient specific bone graft tomore closely conform to the patient's natural anatomy. This can allowthe surgeon to modify the bone to a lesser extent or even to just applythe patient specific bone graft to the glenoid without much or anymodification.

To achieve more complex configurations, the contoured surface 808 can bebased on three dimensional spatial location information obtained in thestep 104 of FIG. 2. The patient specific insert negative 800 isconfigured to be mounted on or in a bone press, for example as describedbelow. The bone press and the patient specific insert negative 800, 800′cooperate to shape the volume of bone material, which can be formed as abone graft blank, as discussed below, upon application of pressure inthe bone press.

The second side 806′ is configured to mate with a bone press asdiscussed in greater detail below in connection with FIGS. 9-11E. Thesecond side 806, 806′ can have a surface 840 for engaging a surface of acompression plate 644 of the bone press 600. The compression plate 644can include a surface oriented perpendicular to a direction of advanceof the compression plate 644 in the press 600, which generallycorresponds to the axis C. The second side 806′ can also be configuredwith a keyed projection 844′. The keyed projection 844′ can beconfigured to be received in a slot 657 of the bone press 600 of FIGS.9-11E or in a slot 580A of the compression plate 528A of the bone press500A of FIG. 6A. A keyed interface between the keyed projection 844 andthe slot 657 (see FIG. 11(C)) provides a secured interface between thenegative 800 and the bone press 600. The projection 844 and the slot 657retain the insert negative 800 in a fixed rotational position. The fixedrotational position prevents rotation of the first surface 804 relativeto an opposing surface of the bone graft blank B as discussed furtherbelow.

The second side 806 of the insert negative 800 can include a generallyflat surface 840 although it may be rounded toward the periphery. In oneembodiment, the insert negative 800 includes a keyed projection 844 thatextends along the peripheral surface 807. The projection 844 can extendlaterally into a longitudinal channel 580 discussed in more detailbelow. The peripheral surface 807 can include indicia 849 that areuseful in confirming a degree of compression of the bone graft blank Bas discussed further below. The indicia 849 are patient specific in thatthey may provide a relationship between the surfaces 812, 816 and adegree of compression due to movement of the surfaces in a bone press asdiscussed further below.

Further features that are convenient for integrating the patientspecific bone insert negative 800 into a bone press are discussed belowin connection with the bone press 600.

The method of FIG. 2 can advantageously be performed in a number ofdifferent settings. For example, a special facility can be used to formthe patient specific insert negative 800. The insert negative 800 willbe subject to high compression, e.g., pressures and forces, in someembodiments. The insert negative 800 will be formed of a material thatwill not yield under such conditions. Suitable materials include one ormore of stainless steel, maraging steel, cobalt chromium, inconel,nickel alloys, aluminum, titanium, PEEK, and other polymers.

In one process flow, step 104 is performed at an imaging center that canbe run by the surgeon or at a separate facility. Data generated in thestep 104 can be transmitted by any means to a manufacturing facilitythat can create the insert negatives. In another approach, the step 108can be performed with equipment that could be located in a factory or ina surgeon's facility. For example, direct laser metal sintering andother three-dimensional printing technologies could be adapted to bedeployed in either setting to form the patient specific insert negative800 in the step 108.

FIG. 3 illustrates another method 200 that can be performed by animplant manufacturer or a surgeon. The method 200 will be discussed inconnection with certain features of a bone press 500, shown in FIGS.5-7E. However any other bone press compatible with the method could beprovided, including any of the bone presses described herein. In oneapproach, the method 200 is performed by the surgeon or surgical staffor under a supply agreement between the surgeon and a third party.

In a step 204 the bone press 500 is provided. The bone press 500 isprovided with the patient specific insert negative 800. The patientspecific insert negative 800 can be produced by the method 100 orotherwise. The negative 800 can be produced by a third party andsupplied to the party performing the method 200.

The patient specific insert negative 800 can be provided in a pressingzone 540 of the bone press 500. The pressing zone 540 includes a volumethat is contained within structures of the bone press 500. For example,as discussed below the bone press 500 includes a base 504, a housing508, and an actuator 512. The pressing zone 540 is defined in the bonepress 500 between ends thereof by the base 504 and the patient specificinsert negative 800. An outer bound of the pressing zone 540 is definedby an inside surface 510 of the housing 508. The housing 508 can be asolid cylindrical sleeve. In some embodiments, the housing 508 is clearor has a clear portion such that compression of the bone graft blank Btherein can be observed by the user. The housing 508 can have an innerdiameter that is about the same dimension as an outer diameter of acylindrical bone graft blank B. In one embodiment, the bone graft blankB is about 25 mm in diameter and the inner diameter of the housing 508is about 25 mm. In another embodiment, the bone graft blank is about 25mm in diameter and the inner diameter of the housing 508 is about 26,about 27, about 28, about 29, or about 30 mm. In another embodiment, theinner diameter of the housing 508 can be 20-30% larger than the diameterof the bone graft blank B.

The housing 508 could be formed with indicia instead of or in additionto the insert negative 800 to provide feedback to the user as to thedegree of compression of a bone graft blank in the bone press 500.

In step 208 a bone graft blank B is placed in the pressing zone 540.Although the bone graft blank B can be placed directly on the base 504,in certain variants of the method another structure can be placed on thebase 504 and that other structure can define an end or a portion of thepressing zone 540.

FIGS. 5-7E illustrate methods when the glenoid component 10′ optionallyis placed on the base 504. In a modified embodiment, the methods ofFIGS. 5-7E can be performed without the glenoid component 10′ placed onthe base 504, e.g., with a bone graft blank placed directly on the base504. The glenoid component 10′ defines a portion of the pressing zone540. In particular, the medial face 34 of the glenoid component 10′ canform an end of the pressing zone 540. As discussed above, the glenoidcomponent 10′ has anchor member 12′. The opposing face 32 provides anend of the pressing zone 540. In one variation of the method 200, theanchor member 12′ is disposed in the pressing zone 540. The step 208 caninvolve placing a cylindrical bone graft blank B over the anchor member12′. In this variation, the anchor member 12′ is radially inward of andis surrounded by the bone graft blank B. In this variation, the bonegraft blank B is radially inward of and is surrounded by the housing508. The pressing zone 540, e.g., the space where compression of thebone graft blank B occurs, can be at least partially defined between theanchor member 12′ and the housing 508.

The method 200 can continue with a step 212 in which the bone graftblank B is placed under compression. The compression can be due topressure being applied to medial and lateral ends B₁, B₂ of the bonegraft blank B. The compression can be due to a force being applied tomedial and lateral ends B₁, B₂ of the bone graft blank B. Compressioncan be applied in the pressing zone 540 by providing relative motionbetween the patient specific insert negative 800 and the base 504 or aportion of the base 504 or of a component coupled with the base.

The step 212 can involve actuating the patient specific insert negative800 and thereby moving the negative 800 toward the cover 504 asindicated by an arrow A in FIG. 6. In the bone press 500, the patientspecific insert negative 800 is moved toward the base 504 by theactuator 512. The patient specific insert negative 800 is moved byrotating a screw member or ram 524 to advance a compression plate 528toward the base 504. The compression plate 528 can include a rigid plateconfigured to couple with the patient specific insert negative 800.

Other structures that could be used to move the patient specific insertnegative 800 into compression with the bone graft blank B can include alever arm (discussed below in connection with 12-14B), a pneumaticmechanism, or other similar mechanisms. The actuator 512 can be handoperated or automatically driven. The actuator 512 can have a handlewith an arcuate form between lateral ends thereof to conform to theshape of the palm of the hand of a user.

In a step 216, the bone graft blank B is reshaped to form a patientspecific bone graft. For example, the compression provided in the step212 can be continued or increased until ends of the bone graft blank Bchange their shape in a suitable manner. The reshaping can involveshortening the bone graft blank along the axis C by 25-75%, by 35-65%,for example by about 50%. The reshaping can include modifying a planaror irregular medial side or end B₁ of the bone graft blank B to have aspecified profile. For example, as discussed above the first side 804 ofthe insert negative 800 can have a profile that matches a glenoid shapeor a shape to which the glenoid will be modified in a surgicalprocedure. In one example, the glenoid is to be reamed to planar facesthat are disposed along a contiguous boundary but angled to one another.In such case, the insert negative 800 is formed to have a shape thatmatches that of the glenoid or the shape to which the glenoid is to bemodified. In the step 216, the insert negative 800 can have two angledfaces on the medial side as shown in FIG. 8(B). The compression can becontinued or increased by continuing to move the insert negative 800toward the base 504 after initial contact is made between the insertnegative 800 and the bone graft blank B. Such movement can continue for10-20 mm or for up to about 50% or even as much as 60%, 65%, or even 70%of the initial uncompressed length of the bone graft blank B. The step216 causes the bone graft blank B to be compressed and to conform to asurface of the negative 800 and generally to irreversibly deform so asto hold the shape once compression is removed. This is not an elasticdeformation only where the bone springs back to its initial shape oncecompression is removed, though some limited recoil may occur.

FIG. 4 illustrates a method 300 in which three dimensional spatiallocation information is obtained and a patient specific bone graft isproduced. This method can be conducted by or under the direction of asurgeon or by or under the direction of a third party, such as animplant manufacturer. The method 300 includes a step 304 in which threedimensional spatial location information is obtained. The step 304 canbe similar to the step 104, such as including the conducting of a CTscan or x-ray of a relevant portion of a patient's bone or joint.

In a step 308 a prosthesis component, such as the component 10′,optionally is placed in a bone press. With reference to FIG. 7A, thecomponent 10′ can be placed directly onto the base 504 of the bone press500. In another variation, the component 10′ can be placed on animpactor 690. Thereafter, a portion of the impactor 690 and theprosthesis component can be placed in the bone press together. Inanother variation, the component 10′ is not placed in the bone press 500during a method of forming a patient specific bone graft.

In a step 312, a bone graft blank, such as blank B, is placed in thebone press 500. FIG. 6 shows that the bone graft blank B can be placedin the bone press 500 in a location between the base 504 and the patientspecific insert negative 800. In one method, an end or lateral side B₂of the bone graft blank B faces toward the base 504 and an end or medialside B₁ faces toward the patient specific insert negative 800. Asdiscussed above, the bone graft blank B can take any suitable form. Insome cases the bone graft blank B is a cylinder of bone with the sidesB₁, B₂ being generally flat opposing sides and having a generallycircular body extending therebetween. The bone graft blank B can beobtained from a resected portion of the humerus or from another bonesegment. As a result, in some cases, the bone graft blank B can be moreirregularly shaped as a result of being cut during a procedure from thepatient undergoing shoulder replacement. The bone graft blank B also caninclude two or more pieces that are placed into the housing 508 andlater compressed into a single graft.

In one technique, the prosthesis component 10′ with the bone graft blankB mounted thereon is placed in a bone press, such as the press 500. Asshown in FIG. 7(A), for example, the component 10′, which has an anchormember 12′, can have a central lumen B₃ of bone graft blank B placedthereover. The lumen B₃ can be sized to permit the bone graft blank B tobe slipped over the anchor member 12′. So, in one variation the step 312includes providing relative motion between the anchor member 12′ of thecomponent 10′ and the bone graft blank B such that the anchor member 12′is moved into the lumen B₃. After the bone graft blank B is mounted onthe prosthesis component 10′, the component and the blank can be placedinto the bone press 500. In a variation, the prosthesis component 10′ isnot placed in the bone press 500. The blank B can be placed directlyonto the base 504 or another component of the bone press 500.

FIG. 6 shows that when the bone graft blank B is placed in the bonepress 500 the medial side B₁ is adjacent to the patient specific insertnegative 800. In one approach no components are placed between themedial side B₁ and the first side 804 of the negative 800. Directcontact can be provided between the medial side B₁ and the first side804 of the negative 800. Direct contact allows the surface profile ofthe medial side B₁ and the first side 804 to be provided on the bonegraft blank B as discussed further below.

In a step 316 the bone graft blank B is compressed in the bone press.FIG. 6 shows that the bone graft blank B is compressed in the pressingzone 540 between the patient specific insert negative 800 and thecomponent 10′. More generally, the bone graft blank B is compressedbetween the patient specific insert negative 800 and the base 504. Thecompression provided in the step 316 is initially axial compression.Axial compression is along the direction of the arrow A (FIG. 10). Afteran initial level of compression, the bone graft blank B may expandtransverse to the direction A to some extent. However, the pressing zone540 of the bone press 500 is enclosed by the housing 508. So expansiontransverse to the lumen B₃ is limited. The bone graft blank B isdisposed between the anchor member 12′ and the housing 508. Thisconfiguration can provide compression in the transverse direction.

In a step 320 the bone graft blank B is reshaped. The step 320 caninvolve changing the length of the body of the bone graft blank B from afirst length to a second shorter length, as discussed above inconnection with the method of FIGS. 3. The step 320 can involveincreasing the outer profile of the bone graft blank B, for example froma first radius to a second larger radius. If the shape of the medialside B₁ of the bone graft blank B has not been modified upon compressionin the step 316, the step 320 can involve changing the side B₁ to ashape matching, but a negative of, that of the bone to which the bonegraft blank B will be mated after it is changed into a patient specificbone graft. The step 320 causes the bone graft blank B to be compressedand conformed and generally to irreversibly deformed so as to hold theshape once compression is removed. This is not an elastic deformationonly where the bone springs back to its initial shape once compressionis removed, though some limited recoil may occur.

Following the method of FIGS. 3 and 4 the bone graft that is shaped inthe bone press 500 (or other bone press) can be removed. If the initialdiameter of the bone graft blank B is similar to the inner diameter ofthe housing 508 an ejector tool can be used to push the bone graft outof the housing 508. The ejector can include an elongate solid rod with ahandle at one end and a disk or other pushing plate at the other end.The disk or pushing plate is configured to mate with and push the bonegraft out of the housing 508. A kit including the bone press 500 (orother bone presses disclosed or claimed herein) can include an ejector.

Bone Graft Presses

Turning now to FIGS. 5-14B a variety of bone graft presses will bediscussed in greater detail. The bone graft presses of these embodimentscan be hand operated. FIGS. 5 and 9 illustrate bone presses in which anactuator is provided that includes a threaded connection. FIG. 12 showsa bone press that includes a single motion actuator, e.g., anon-threaded actuator, e.g., an actuator with a lever, to providecompression of a bone graft blank B. The bone graft presses can be usedto form a patient specific bone graft directly on a component to whichthe bone graft is to be coupled. FIGS. 5-7(E) illustrate bone pressesthat form a patient specific bone graft directly on a glenoid baseplateto be coupled with an impactor or other surgical tool after the patientspecific bone graft is formed. FIGS. 9-14(B) show a bone press thatpermits an impactor to be coupled with a glenoid baseplate prior to theformation of the bone graft in the bone press such that the baseplateand the bone graft are ready to be implanted immediately after the bonegraft is removed from the bone press.

FIGS. 5-7(E) illustrate the bone press 500 in greater detail. The bonepress 500 is configured to receive the bone graft blank B and theprosthesis component 10′ together in the pressing zone 540. In otherembodiments the bone graft blank B could be placed the pressing zone 540without the component 10′. The actuator 512 of the bone press 500includes a threaded mechanism for advancing the actuator 512 toward thebase 504 which allows for a large amount of compression, if desired.

FIG. 5 shows that the base 504 can comprise a plate-like configuration.That is, a lower surface 544 can be planar in shape allowing the base504 to rest on a table or other flat surface in use. The lower surface544 would be the bottom of the bone press 500 in such arrangements withan upper part of the actuator 512 being the top of the bone press. Thebone press also can include two side surfaces 548 to which the actuator512 is coupled. The side surfaces 548 can include threaded apertures 550to which threaded members 552 of the actuator 512 can be coupled (seeFIG. 6). In one embodiment the threaded apertures 550 comprise endportions of one elongate lumen that extends from one of the surfaces 548to the other of the surfaces 548.

FIG. 7(A) shows that an upper surface of the base 504 can include aplatform 555 configured to couple with the component 10′ or other jointcomponent. The platform 555 preferably allows the component 10′ to bequickly coupled with the platform 555 to prevent rotation of thecomponent 10′ relative to the platform 555. For example a central post556 can be provided that can be received into an aperture of thecomponent 10′. One or more peripheral posts 557 can be provided spacedapart from the central post 556. The peripheral posts 557 also arereceived in apertures of the component 10′. The peripheral posts 557prevent any torque that may be induced in the pressing zone 540 fromresulting in rotation of the component 10′ or from transmission oftorque transferred between the upper surface 554 and the component 10′from being applied to the bone graft blank B. Providing isolation fromsome or substantially all such torque can be important if the materialof the bone graft blank B is fragile because the goal of the bone pressis to output a solid patient specific bone graft that will not crumblein subsequent using during a joint implantation procedure. The platform555 can also be a locally elevated portion of the upper surface of thebase 504. For example, upward cylindrical projection 558 can be providedon the upper surface of the base 504. The projection 558 allows thecomponent 10′ to come to rest at an elevation above a portion of theupper surface 554 located outward of the projection 558. The projection558 can have a circular periphery with an outer radius less than theinner diameter of the housing 508 such that the housing can be advancedover the projection 558 and come into contact with the upper surface 554at a location outward of the projection 558. This configuration allowsthe entire platform 555 to be received in the housing 508 during thecompression of the bone graft blank B.

FIGS. 5 and 6 show the actuator 512 in more detail. The actuator 512includes a frame 559 that provides a rigid connection to the base 504.In one embodiment the frame 559 includes two bars 560 that are pivotallyconnected at a first end 562 to the base 504 by the threaded members552. The bars 560 include an elongate rigid portion that extends fromthe first end 562 to a second portion 564 at which the bars 560 arelinked. The second portions 564 can be linked by a transverse bar 566.In some configurations, the bars 560 and the transverse bar 566 areportions of a unitary construction, e.g., they can be monolithic, theycan be a single piece, and/or they can be seamless without boundariesbetween them. The bars 560 and the bar 566 (if present) transfer forcesbetween the base 504 and a compression plate 528 of the actuator 512.The compression plate 528 is advanced by action of a handle 567.

FIGS. 5 and 6 show that the compression plate 528 can be placed betweenthe handle 567 and the base 504. A ram 524 is coupled at one end withthe compression plate 528 and at an opposite end with the handle 567.The ram 524 is configured to be advanced relative to the transverse bar566, for example by a threaded connection. The ram 524 can have athreaded external surface 568 that mates with internal threads of a hole570 formed in the inside surface of a hole formed in the transverse bar566.

The connection between the handle 567 and the ram 524 can be anysuitable connection. A suitable connection will transfer torque from thehandle 567 to the ram 524 such that rotation of the handle istransferred directly into rotation of the ram. Such connection willgenerally prevent any relative rotation between the handle and the ram.The handle 567 can be directly coupled to the ram 524, such as by a pinor screw to assure one-to-one rotation between these components. Thehandle 567 and the ram 524 could be formed as a single component, e.g.,be unitary in some configurations. The connection between the ram 524and the compression plate 528 preferably is one which advancement of theram 524 toward the base 504 is transferred one-to-one to the compressionplate. The compression of the bone graft blank B that is preferred isprimarily or substantially only in the axial direction. In this context,the axial direction is a direction defined along the central axis of thelumen B₃. The axial direction also can be defined as perpendicular toone or both of the surfaces B₁, B₂ of the bone graft blank B. To provideno or substantially no circumferential compression of the bone graftblank B the compression plate 528 is configured to remain rotationallyfixed during advancement of the compression plate. Relative rotation ofthe compression plate 528 is provided by the connection between theplate 528 and the ram 524.

FIG. 6 shows one mechanism for providing relative rotation between thecompression plate 528 and the ram 524. In particular, a coupler 572 canbe provided between an upper side of the compression plate 528 and theram 524. The coupler 572 can include a stepped cylindrical recess 574formed in the ram 524. The recess 574 can more generally be an arcuatechamber in some embodiments. The lower end of the ram 524 can receive apin or axle with an arcuate surface 576 defined thereon. The arcuatesurface 576 can optionally be stepped and preferably has a slip fitrelative to the recess 574. The coupling of the cylindrical recess 574and the arcuate surface 576 provide for rotation of the compressionplate 528 relative to the ram 524. Although shown as a pin and recessconnection, the connection could be one that provides at least oneadditional axis of rotation

FIG. 6A shows another embodiment of a bone press 500A that is similar tothe bone press 500 except as described or illustrated differently. Thebone press 500A has a mechanism for providing relative rotation betweena compression plate 528A and a ram 524A. In particular, a coupler 572Acan be provided on an upper side of the compression plate 528A. Thecoupler can have an arcuate chamber 574A defined therein. The arcuatechamber 574A is at least partially spherical in one embodiment. Thelower end of the ram 524A can have an arcuate surface 576A definedthereon. The arcuate surface 576A can comprise an at least partiallyspherical surface. The coupling of the arcuate chamber 574A and thearcuate surface 576A provide for relative rotation of the compressionplate 528A relative to the ram 524A. Although shown as a ball and socketconnection, the connection could be one that provides relative rotationabout fewer axes, e.g., about two axes. Also, the compression plate 528Acan have a keyed arrangement formed thereon, as discussed further below.

FIGS. 7(A)-7(E) show how the bone press 500 is used. In FIG. 7(A), theram 524 and the compression plate 528 are raised by actuating the handle567 to a position spaced away from the base 504. The plate 528 can bemoved as far away from the base 504 as possible, in a position that maybe described as fully retracted. The threaded members 552 can beloosened if necessary to permit the actuator 512 to be moved away fromthe platform 555 to allow access to the platform. The component 10′ orother similar component can then be placed on the platform 555.Apertures in the component can be placed over the central and peripheralposts 556, 557. In this position the component 10′ is secured to theplatform 555 against undesirable rotation. The base 504 is rigid andholds the component 10′ against axial movement away from the compressionplate 528.

FIG. 7(B) shows that the bone graft blank B can thereafter by placedover the component 10′. For example, the lumen B₃ of the bone graftblank B can be advanced over the anchor member 12′. The anchor member12′ can be received in the lumen B₃. The lateral surface B₂ of the bonegraft blank B can be placed directly on the medial side of the component10′. FIG. 7(B) shows the component 10′ and the bone graft blank B on thebase 504 in a zone where the pressing zone 540 will be formed. Thecomponent 10′ and the bone graft blank B are disposed on the projection558 at an elevation above the surrounding areas of the platform 555.

FIG. 7(B) shows that the housing 508 and the patient specific insertnegative 800 are spaced apart from the rest of the bone press 500 atthis point of one method. These components could be at the surgicaltable or on a back table in the operating room or could be elsewhere ifthe bone graft blank is formed well before the surgery.

FIG. 7(C) shows a later step in which the housing 508 is advanced overthe bone graft blank B. The housing 508 can be advanced over the bonegraft blank B and over the component 10′ if present. In the illustratedmethod, the housing 508 is advanced over the blank B, the component 10′and over the projection 558 into contact with a surrounding portion ofthe platform 555. In this position the pressing zone 540 is enclosedother than an upper portion where the patient specific insert negative800 is to be placed.

FIG. 7(C) also shows a clocking element 578. The clocking element 578provides pre-defined rotational position of the patient specific insertnegative 800 relative to the housing 508. For some embodiments, specificorientation of the negative 800 relative to a bone press is useful forproviding proper orientation or position of an augment on anasymmetrical bone graft. For example if a bone graft has an oblong,e.g., rectangular, cross section and the augment is to be provided at aspecific region, e.g., along a long axis or a short axis of the bonegraft, the position of the insert negative 800 relative to the housing508 should be pre-defined to assure that the negative 800 produces theaugment in the desired location. In other embodiments it is sufficientthat the rotational position of the negative 800 relative to the housing508 or the pressing zone 540 is sufficient to prevent circumferentialcompression which could result in shearing of the bone graft blank B. Inone embodiment the housing has a cylindrical configuration with theinner periphery of the housing 508 being circular. At one or morelocations of the inner periphery the periphery extends outwardly to forma longitudinal recess or channel 580 in the inner surface. Thelongitudinal channel 580 allows a projection 582 on the outer surface ofthe patient specific insert negative 800 to be received and to slide asthe negative 800 is advanced in the housing 508. The channel 580 and theprojection 582 engage to prevent relative rotation of the negative 800and the housing 508 during such advancement. In another embodiment, theclocking element 578 can include channels on the patient specific insertnegative 800 and projections on the housing 508. The channels orprojections extends or extend from an upper surface of the housing 508toward the lower surface thereof. The channel(s) or projection(s) canextend entirely between the upper and lower portions of the housing 508.Although the illustrated embodiment has only one channel 580, theclocking element 578 could include a plurality of channels 580 orprojections if the purpose of the clocking element 578 is only forpreventing rotation during movement of the patient specific insertnegative 800.

FIG. 7(D) shows the insert negative 800 placed into the housing 508. Theprojection 582 is received in the channel 580. This provides a specificrotational position and also prevents or limits circumferentialcompression.

FIG. 7(E) shows the compression plate 528 moved into contact with anupper surface 840 of the patient specific insert negative 800. After thecompression plate 528 is in such contact, the handle 567 can be actuatedto move the ram 524 and the compression plate 528 coupled therewithtoward the base 504 to create compression of the bone graft blank B.Such compression can begin to compress the bone graft blank B. Furthercompression can cause the bone graft blank B to be reshaped. Thereshaping of the bone graft blank can cause the medial surface of thebone graft blank B to form a shape matching the shape of the glenoidsurface either as it is prior to surgery or after a prescribed amountand type of reaming. After the compression and/or reshaping the bonegraft blank B is formed into a patient specific bone graft B′.

FIG. 7(F) shows that in one example the patient specific bone graft B′has a first side that is or can be coupled with the prosthesis component10′ and a second side. The patient specific bone graft B′ configured forthe shoulder will have a contoured surface B₁′ that corresponds to ashape of a glenoid. The surface B₁′ is a patient specific bone facingportion, e.g., a portion that is configured to face glenoid of apatient. That is, the contoured surface B₁′ is a negative of the surfaceof the glenoid. The contoured surface B₁′ can have a first planarportion B₄ and a second planar portion B₅. The planar portions B₄, B₅are configured to be nested in and to closely match the surfaces of theglenoid that are unaltered or that have been prepared by minimal reamingor other preparation method. The patient specific bone graft B′ has abody that extends between the surface B₁′ and a surface B₂ opposite thesurface B₁′. The body of the bone graft B′ is configured to adjust thespacing of a prosthesis component coupled with the side or surface B₂from a surface of the bone to which the contoured surface B₁ or patientspecific bone facing potion is coupled. The specific bone graft B′generally is compressed, as discussed herein within any of the bonepresses herein. The specific bone graft B′ can be formed from a single,monolithic piece of bone or from a plurality of pieces of bone. Thespecific bone graft B′ can comprise natural bone matter or syntheticbone matter. The specific bone graft B′ can include a lumen B₃therethrough configured to receive a portion of a prostheses, such asthe component 10′ as shown herein.

FIG. 9 shows another embodiment of a bone press 600 that can be used tocompress or reshape a bone graft blank B. The bone press 600 is similarto the bone press 500 except as described differently below. The bonepress 600 includes a pressing zone 604 defined within a housing 608. Thehousing 608 includes a first shell 612 and a second shell 616. The firstshell 612 comprises at least a portion of a base 620 configured tosupport either directly or indirectly the advancement of the patientspecific insert negative 800. In the illustrated embodiment, the firstshell 612 includes a first portion of the base and the second shell 616comprises a second portion of the base 620. In a variation the base 620is disposed on only one of either the first shell 612 or the secondshell 616.

The first shell 612 and the second shell 616 meet at an interface, whichcan be a planar interface. FIGS. 9 and 10 show that each of the firstshell and the second shell 612, 616 comprises a portion of an accessaperture 624 for receiving a shaft 692 of the impactor 690. The aperture624 allows the impactor 690 to pass through the base 620 into thepressing zone 604 within the bone press 600.

The shells 612, 616 can each have a partially cylindrical configuration.For example a cylinder portion 628 can extend away from the portion ofthe base 620 formed by the shell 612 toward an end of the bone press 600opposite the base. A cylinder portion 632 can extend away from theportion of the second shell 616 toward the opposite end. The cylinderportions 628, 632 can be half cylinders in one embodiment. The insidesurfaces of the cylinder portions of the shells 612, 616 form thepressing zone 604. The outside surfaces of the cylinder portions arethreaded to enable advancement of an actuator 636 as discussed below.

The shells 612, 616 can have one or more slots 640 formed therein. Theslots 640 are configured to permit a mechanical connection between theactuator 636 and a compression plate 644 disposed in the pressing zone604. In various embodiments there may be one, two, three, four, five,six, or more slots 640. In the illustrated embodiment, there are fourslots 640. Each of the shells 612, 616 has one slot 640 formed entirelytherein. A slot 640 is formed on each side of the bone press along theinterface between the shells 612, 616.

The compression plate 644 includes a central portion 652 that can bedisposed inside the pressing zone 604 of the bone press 600 and forcetransfer projection 656 extending peripherally from the central portion652. The compression plate has a force transfer projection 656 for atleast one of the slots 640. The compression plate 644 can have one forcetransfer projection 656 for each of the slots 640, as illustrated in theFIG. 11(C). By disposing the force transfer projections 656 through theslots 640 the force transfer projections can be engaged by the actuator636 as discussed below. The projections 656 can comprise an enlargedlobe disposed outside the slot 640 and a narrow portion between the lobeand the central portion 652.

The actuator 636 comprises a cylindrical portion 664 at a first end 668that includes a threaded interior 670. The first end has a distal face671 that acts on the compression plate 644. The interior threads areconfigured to engage the exterior threads disposed along the shells 612,616. The threads on the shells 612, 616 and on the interior 670 enableadvancement of the actuator 636 along the shells. The advancement of theactuator 636 engage the compression plate 644 to push the compressionplate into the bone graft blank B to compress and/or re-shape the bonegraft blank. The actuator 636 has an enlarged hand grip 672. The handgrip 672 can include one or more enlarged members that the hand grip 672can engage. The hand grip 672 can help increase the torque by extendingfarther than does the cylindrical portion 664 away from an axis ofrotation of the actuator 636 about the shells 612, 616.

FIGS. 11(A)-11(E) illustrate the use of the bone press 600. The impactor690 has a first end with a handle 678 and a second end with engagementfeatures 680 to connect the impactor 690 with the component 10′. FIGS.11(B) shows that the user can therefore connect the lateral side of thecomponent 10′ to the engagement features 680 of the impactor 690.Thereafter the bone graft blank B can be coupled with the component 10′.For example, thereafter lumen B₃ of the bone graft blank B can be placedover the anchor member 12′. The anchor member 12′ can be inserted intothe lumen B₃ from the lateral side B₂ of the bone graft blank B untilthe lateral side of the bone graft blank B engaged the medial side ofthe component 10′.

FIG. 11(C) shows that after the component 10′ and the bone graft blank Bare coupled with the impactor 690 these components can be coupled withthe bone press. For instance, the shaft 692 of the impactor 690 can belaid in a lower portion of the access aperture 624. When so placed, thecomponent 10′ and the bone graft blank B are disposed in the insideportion of the first shell 612. The lateral side of the portion of theimpactor 690 carrying the engagement features 680 (see FIG. 11(A)) canbe placed in the first shell 612 such that the lateral side of theimpactor is in direct contact with the base 620. Thereafter the patientspecific insert negative 800 and the compression plate 644 are placed inthe pressing zone 604, e.g., into the interior surface of the firstshell 612. Specifically, the keyed projection 844 on the second side 806of the negative can be received in a corresponding slot 657 of thecompression plate 644. In one technique the keyed projection 844 isreceived in the slot 657 and thereafter the slot 657 and the plate 644are placed in the first shell 612 such that the contoured surface 808 ofthe insert negative 800 faces the bone graft blank B and such that thebone graft blank B is between the base 620 and the compression plate644. FIG. 11(D) shows the foregoing arrangement.

Following placement as in FIG. 11(D), a block 682 coupled with thesecond shell 616 is placed over a bottom portion of the base 620. Theblock 682 can be manipulated by a handle 684 coupled with the block 682.The block 682 can be coupled with a bottom portion of the base 620 in asuitable fashion. For example, a plurality of projections 686 disposedon the lower side of the block 682 can be received in a correspondingplurality of apertures 688 formed on the lower side of the base 620. Theillustrated embodiment shows that three projections 686 can be receivedin three corresponding apertures 688 shown in the illustratedembodiment.

FIG. 11(E) shows the second shell 616 coupled with the first shell 612.Thereafter the actuator 636 can be threaded onto the free end of theshells 612, 616. The threading of the actuator onto the shells 612, 616is facilitated by the hand grip 672. Further threading, as indicated byarrow A (see FIG. 10), causes the projections 656 of the compressionplate 644 to be engaged by the distal face 671 of the actuator 636opposite the hand grip 672. Further threading causes the actuator 636 toengage the projections 656 moving the compression plate 644 toward thebone graft blank B. After compression has begun further advancement ofthe actuator 636 can cause the bone graft blank B to be reshaped suchthat the bone graft blank can be re-formed from a generic shape to ashape specifically configured for a particular patient, as discussedabove.

FIG. 5-7(E) illustrate that the bone press 500 provides the benefit ofhigh compression capability due to the threaded connection between theram 534 with the benefit of compressing and/or reshaping the bone graftblank B into the patient specific bone graft right on the component 10′.By forming the bone graft on the component 10′, the surgeon or anotheruser can avoid transferring bone graft to the component 10′ which wouldrequire an additional step and/or could result in damage to the bonegraft.

FIG. 9-11(E) illustrate that the bone press 600 provides the benefit ofhigh compression capability due to the threaded connection between theactuator 636 and the shells 612, 616 with the benefit of having,pre-loaded onto the impactor 690, the component 10′ and the formedpatient specific bone graft formed from the bone graft blank B in thebone press 600. As a result, the surgeon is not required to load thebone graft and the component 10′ onto the impactor 690. By forming thebone graft and the component 10′ preloaded on the impactor the surgeonor another medical professional can avoid transferring the bone graftand the component 10′ to the impactor 690 which would require anadditional step and/or could result in the bone graft being displaced onor from the component 10′.

FIGS. 12-14(B) show another bone press 700 that can be used to form apatient specific bone graft from a bone graft blank B. The bone press700 provides a number of advantages, including forming the bone graft onthe impactor 690 and enabling formation of the bone graft through asingle pre-defined motion among other advantages.

The bone press 700 includes a compression plate 702, a base 704, ahousing 708, and an actuator 712. The compression plate 702 comprises arigid plate-like configuration. The compression plate 702 has a firstside 720 with a platform 722 and a second side 724 opposite the firstside 720. The compression plate 702 has lateral sides 728 to which theactuator 712 is coupled. The actuator 712 is coupled to the compressionplate 702 at the lateral sides 728 by a plurality of pins 730, butthreaded members or other connection devices could be used. The firstside 720 includes a keyed interface that can include a linear protrusion732 that retains the patient specific insert negative 800 in apre-defined rotational position relative to the bone graft blank B. Thekeyed interface also can include a peg 733 projecting away from thefirst side 720 of the compression plate 702 and away from the linearprotrusion 732 toward the base 704. The patient specific insert negative800 has a corresponding groove or slot 734. The slot 734 is sized toreceive the protrusion 732 of the interface. If provided, the peg 733 isreceived in an aperture, recess or a lumen 850 of the patient specificinsert negative 800 (See FIG. 13). Other couplings could be providedbetween the patient specific insert negative 800 and the compressionplate 702. For example, a plurality of pegs could be provided projectingfrom the first side 720 to mate in only one orientation with the patientspecific insert negative 800. The pegs could be on the patient specificinsert negative 800, to mate with apertures in the compression plate702. The interface 732 could be on the patient specific insert negative800 to mate with the groove or slot 734 formed on the compression plate702. Other variations are also possible.

The base 704 has a first side 742 and a second side 744. The base 704 isdisposed opposite the compression plate 702 in the bone press 700. Thesecond side 744 faces the compression plate 702. The housing 708 extendsbetween the base and the compression plate. The housing 708 has a firstend 746 that contacts the compression plate 702 and a second end 748that contact the base 704. A pressing zone 750 is formed between thepatient specific insert negative 800 (mounted on the compression plate702), the base 704, and the housing 708. As discussed herein, thepressing zone 750 is a place where compression of the bone graft blank Bcan occur. The base 704 also includes an access path 754 for receivingthe impactor 690. The access path 754 preferably extends from one of thesides of the base 704, e.g., from a top side of the base 704. The accesspath can comprise a U-shaped recess formed form the top side of the baseto a central portion of the base, e.g., to a position aligned with acentral longitudinal axis of the pressing zone 750.

The actuator 712 comprises a pair of bars 762 disposed on opposite sidesof the pressing zone 750. The bars 762 are pivotably coupled with thebase 704. Pins 764 extend through the bars 762 and into the base. Thepins 764 permit the bars to rotate from an upright position, shown inFIG. 12, to inclined position, one of which is shown in FIG. 13. Thebars 760 are also rigidly connected by a transverse bar 768. The bars760 are also connected by a force transfer rod 769. Movement between thepins 764 and the bars 762 is limited to rotation in some embodiments.The force transfer rod 769 is able to pivot relative to the bars 760 andalso can slide along slots 770 formed in the bars. The slots 770 areformed in each bar 760, are parallel to each other, and have the samelength in some embodiments. FIGS. 12-14(B) all show the force transferrod 769 at an end of the slot corresponding to a state of compression.The force transfer rod 769 can move toward or to the opposite end of theslot 770, which corresponds to a more open configuration of the bonepress 700. In one embodiment, the slots 770 are eliminated and the bars760 can be pivotably coupled with a force transfer member such withoutany movement of the force transfer member relative to the bars 760. Theactuator 712 also includes a handle 772 that can be grasped by a user inorder to move the actuator 712 between an upright position, as in FIG.12 and an inclined position as in FIG. 13. The upright position is onein which compression can occur in the pressing zone 750. The inclinedposition is one in which compression is reduced or eliminated comparedto the upright position. In some inclined position the pressing zone 750can be opened and accessed to load the component 10′ and/or the bonegraft blank B.

FIGS. 14(A)-14(B) show how the bone press 700 can be used. In theillustrated embodiment, the bone press 700 is configured to compress andreshape a bone graft blank B mounted on the impactor 690. Prior tocompressing the bone graft blank B, the actuator 712 is placed in aninclined position, as shown in FIG. 13-14B. FIG. 13 shows that bonepress 700 can receive the component 10′ as well as the blank B.Accordingly, in one variation of the bone press 700 the component 10′and the bone graft blank B can be mounted to the impactor 690 as shownin FIGS. 11(A)-11(B). The combination of the impactor 690, the component10′ and the bone graft blank B can be coupled with the base 704. In oneembodiment, the shaft 692 is inserted into the access path 754.Thereafter, the component 10′ can be mounted to engagement features 680of the impactor 690 at a location between the base 704 and thecompression plate 702. A bone graft blank B is then advanced over theanchor member 12′.

The pressing zone 750 then can be formed by placing the housing 708 overthe bone graft blank B. The insert negative 800 can be mounted to thepeg 733. The pressing zone 750 can be enclosed by placing the patientspecific insert negative 800 into the housing 708 as shown in FIG. 13.

After the pressing zone 750 is enclosed, the actuator can be moved froman inclined position, as in FIGS. 13-14(B), toward an upright positionas shown in FIG. 12. FIG. 13 shows a gap between the patient specificinsert negative 800 and the medial side B₁ of the bone graft blank B. Afirst movement of the actuator 712 from the inclined position of FIG. 13toward the upright position of FIG. 12 the gap is closed and contactbetween the patient specific insert negative 800 and the medial side B₁of the bone graft blank B. Further movement causes compression of thebone graft blank B. After compression of the bone graft blank B, furthermovement of the actuator 712 reshapes the bone graft blank B. Thereshaping can be such that the bone graft blank B is formed into apatient specific bone graft.

The bone press 700 provides the advantage of transforming the bone graftblank B into a patient specific bone graft without requiring a repeatingmotion, such as threading one member relative to another. Rather, thetransformation can result from a single motion from an inclinedconfiguration (as in FIGS. 13-14(B) or more inclined) to an uprightposition as in FIG. 12. The arrangement of the bars 760, 762 also can bearranged to create a great deal of compression in the pressing zone 750.The amount of compression can be tailored by the location of the forcetransfer member 769 and the handle 772.

Terminology

Although certain embodiments have been described herein with respect toan anatomic component or a reverse component, the implants and methodsdescribed herein can interchangeably use any articular component,including the anatomic and reverse components described herein, as thecontext may dictate.

As used herein, the relative terms “proximal” and “distal” shall bedefined from the perspective of the implant. Thus, proximal refers tothe direction of the articular component and distal refers to thedirection of the base plate when the implant is assembled.

Note that the terms “first” and “second”' articular components can beused interchangeably and to refer to the anatomic components or thereverse components. Accordingly, the “first” and “second” openings canbe used interchangeably and to refer to any one of the openings in thebaseplate.

Conditional language, such as “can,” “could,” “might,” or “may,” unlessspecifically stated otherwise, or otherwise understood within thecontext as used, is generally intended to convey that certainembodiments include, while other embodiments do not include, certainfeatures, elements, and/or steps. Thus, such conditional language is notgenerally intended to imply that features, elements, and/or steps are inany way required for one or more embodiments.

The terms “comprising,” “including,” “having,” and the like aresynonymous and are used inclusively, in an open-ended fashion, and donot exclude additional elements, features, acts, operations, and soforth. Also, the term “or” is used in its inclusive sense (and not inits exclusive sense) so that when used, for example, to connect a listof elements, the term “or” means one, some, or all of the elements inthe list.

The terms “approximately,” “about,” and “substantially” as used hereinrepresent an amount close to the stated amount that still performs adesired function or achieves a desired result. For example, the terms“approximately,” “about,” and “substantially” may refer to an amountthat is within less than 10% of the stated amount, as the context maydictate. As an example, in certain embodiments, the term “generallyperpendicular” refers to a value, amount, or characteristic that departsfrom exactly perpendicular by less than about 10 degrees.

Although certain embodiments and examples have been described herein, itwill be understood by those skilled in the art that many aspects of theglenoid implants shown and described in the present disclosure may bedifferently combined and/or modified to form still further embodimentsor acceptable examples. All such modifications and variations areintended to be included herein within the scope of this disclosure. Awide variety of designs and approaches are possible. No feature,structure, or step disclosed herein is essential or indispensable.

Some embodiments have been described in connection with the accompanyingdrawings. However, it should be understood that the figures are notdrawn to scale. Distances, angles, etc. are merely illustrative and donot necessarily bear an exact relationship to actual dimensions andlayout of the devices illustrated. Components can be added, removed,and/or rearranged. Further, the disclosure herein of any particularfeature, aspect, method, property, characteristic, quality, attribute,element, or the like in connection with various embodiments can be usedin all other embodiments set forth herein. Additionally, it will berecognized that any methods described herein may be practiced using anydevice suitable for performing the recited steps.

For purposes of this disclosure, certain aspects, advantages, and novelfeatures are described herein. It is to be understood that notnecessarily all such advantages may be achieved in accordance with anyparticular embodiment. Thus, for example, those skilled in the art willrecognize that the disclosure may be embodied or carried out in a mannerthat achieves one advantage or a group of advantages as taught hereinwithout necessarily achieving other advantages as may be taught orsuggested herein.

Moreover, while illustrative embodiments have been described herein, thescope of any and all embodiments having equivalent elements,modifications, omissions, combinations (e.g., of aspects across variousembodiments), adaptations and/or alterations as would be appreciated bythose in the art based on the present disclosure. The limitations in theclaims are to be interpreted broadly based on the language employed inthe claims and not limited to the examples described in the presentspecification or during the prosecution of the application, whichexamples are to be construed as non-exclusive. Further, the actions ofthe disclosed processes and methods may be modified in any manner,including by reordering actions and/or inserting additional actionsand/or deleting actions. It is intended, therefore, that thespecification and examples be considered as illustrative only, with atrue scope and spirit being indicated by the claims and their full scopeof equivalents.

Any methods disclosed herein need not be performed in the order recited.The methods disclosed herein include certain actions taken by apractitioner; however, they can also include any third-party instructionof those actions, either expressly or by implication. For example,actions such as “inserting a base plate into a glenoid cavity” include“instructing insertion of a base plate into a glenoid cavity.”

1. A method of forming a joint prosthesis component, comprising: placinga prosthesis component in a chamber of a bone press, the prosthesiscomponent having a medial side and a lateral second side; placing a bonegraft blank in the chamber of the bone press between a contoured surfaceof a patient specific insert negative and the medial side of theprosthesis component, such that a bone contact surface of the bone graftblank is facing the contoured surface of the patient specific insertnegative; and compressing the bone contact surface of the bone graftblank against the contoured surface of the patient specific insertnegative; reshaping the bone contact surface, thereby forming a patientspecific bone graft.
 2. The method of claims 1, further comprisingobtaining the bone graft blank from a bone of a patient for whom thepatient specific bone graft is to be implanted.
 3. The method of claim1, further comprising obtaining the three dimensional spatial locationinformation
 4. The of claim 3, wherein obtaining the three dimensionalspatial location information comprises performing a CT scan of a bonesurface forming a portion of a joint to be coupled with the patientspecific bone graft.
 5. The method of claim 4, further comprisingforming the patient specific insert negative based upon the threedimensional spatial location information.
 6. The method of claim 1,wherein the prosthesis component comprises a baseplate of a shoulderimplant and further comprising: placing the bone graft blank on themedial side of the glenoid baseplate and placing the bone graft blankand the glenoid baseplate into the bone press such that the bonecontacting surface of the bone graft blank faces the contoured surfaceof the patient specific insert negative; and compressing the bone graftblank between the glenoid baseplate and the contoured surface of thepatient specific insert negative; and reshaping the bone contact surfaceto match a lateral portion of a scapula.
 7. The method of claim 6further comprising: mounting the baseplate onto an impacting plate of animpactor and placing the bone graft blank onto the impactor such thatthe baseplate is between the bone graft blank and the impacting plate;and placing the impacting plate, the baseplate, and the bone graft blankinto the chamber of the bone press such that the bone contact surface ofthe bone graft blank faces the contoured surface of the patient specificinsert negative.
 8. The method of claim 1, further comprising: mountingthe prosthesis component onto an impacting plate of an impactor andplacing the bone graft blank onto the impactor such that the prosthesiscomponent is between the bone graft blank and the impacting plate;placing the impacting plate, the prosthesis component, and the bonegraft blank into the chamber of the bone press such that the bonecontact surface of the bone graft blank faces the contoured surface ofthe patient specific insert negative; and compressing the bone graftblank between the prosthesis component and the contoured surface of thepatient specific insert negative; and reshaping the bone contact surfaceto match a bone portion to which the patient specific bone graft is tobe coupled.
 9. The method of claims 1, further comprising threading afirst portion of the bone press on a second portion of the bone press tocompress and reshape the bone graft blank between the prosthesiscomponent and the contoured surface of the patient specific insertnegative.
 10. The method of claims 1, further comprising actuating alever to move a first portion of the bone press toward a second portionof the bone press to compress and reshape the bone graft blank betweenthe first prosthesis component and the contoured surface of the patientspecific insert negative.
 11. A method of forming a bone presscomponent, comprising: obtaining three dimensional spatial locationinformation of a bone portion of a joint; and forming a patient specificinsert negative comprising a contoured surface based on the threedimensional spatial location information, the patient specific insertnegative being configured to be mounted on a bone press and to shape abone graft blank upon application of pressure in the bone press.
 12. Themethod of claim 11, wherein the three dimensional spatial locationinformation comprises a three dimensional contour of a lateral portionof a scapula including at least a portion of a glenoid surface.
 13. Themethod of claim 12, wherein obtaining three dimensional spatial locationinformation comprises performing a CT scan of the glenoid surface orportion of the scapula.
 14. A method of forming a patient specific bonegraft comprising: providing a bone press comprising a patient specificinsert negative disposed in a pressing zone thereof, the patientspecific insert negative comprising a contoured surface based on threedimensional spatial location information of a bone portion to which thepatient specific bone graft is to be coupled; placing a bone graft blankinto the pressing zone; and compressing the bone graft blank against thecontoured surface of the patient specific insert negative to cause abone contacting surface of the bone graft blank to conform to thecontoured surface of the patent specific insert negative, therebyforming a patient specific bone graft.
 15. The method of claim 14,wherein the pressing zone is enclosed by a cover configured to opposeforces applied by the patient specific insert negative to the bone graftblank.
 16. The method of claim 15, further comprising removing the coverand placing the bone graft blank into the pressing zone and thereafterreplacing the cover
 17. The method of claim 16, further comprisingplacing a prosthesis component between the cover and the bone graftblank and, after compressing the bone graft blank, removing theprosthesis component and the patient specific bone graft from thepressing zone.
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